Objective To analyze adverse event (AE) signals of mirikizumab based on the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) and the European database of suspected adverse drug reaction reports (EudraVigilance), to provide references for clinical safe medication.

Methods AE reports of mirikizumab from the first quarter of 2023 to the fourth quarter of 2025 were downloaded from FAERS and EudraVigilance. Signal mining was performed using the reporting odds ratio method and the Bayesian confidence propagation neural network method. Weibull distribution test was employed to evaluate the occurrence patterns of AEs, and the Log-rank test was used to assess differences in cumulative incidence and time to onset of AE between different genders.

Results A total of 622 and 692 AE reports were retrieved from FAERS and EudraVigilance, respectively. Among reports with known gender, the male-to-female ratio was nearly balanced. Among reports with known age, patients were predominantly aged 18-64 years (51.98%). Weibull distribution indicated that AEs mainly occurred within the first month after drug administration [β=0.76, 95%CI: (0.66, 0.88)]. Females experienced significantly earlier AE onset than males (P=0.004 7). Both databases showed that the system organ classes mainly involved in mirikizumab AEs were general disorders and administration site conditions, and gastrointestinal disorders, which were consistent with the information in the drug labeling. A total of 28 AE signals were identified in FAERS, 15 of which overlapped with those from EudraVigilance. Among these, 12 signals were not included in the drug labeling. Injection site reactions exhibited stronger signal strength in patients under 65 years old. In contrast, cardiovascular and cerebrovascular disorders, infections, and thrombotic AEs showed higher signal intensity in patients aged 65 years and above.

Conclusion During the treatment period, in addition to focusing on common AEs of mirikizumab, monitoring of new adverse events should be strengthened. The first month of treatment is a critical window period for risk management. Special attention should be paid to the safety of medication in female patients, elderly patients and other special populations.

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